NAC639.6957. Duties of wholesalers; repair and maintenance of medical products; hours of operation; consumer complaints.

     1. A medical products wholesaler shall:

     (a) Employ a facility administrator and other employees sufficient to operate, set up, repair, maintain and service all medical products sold, leased or otherwise provided by the medical products wholesaler.

     (b) Ensure that employees of the medical products wholesaler are trained to operate, set up, repair, maintain and service the medical products sold, leased or otherwise provided by the medical products wholesaler.

     (c) Ensure that employees of the medical products wholesaler are trained to instruct medical products providers regarding the operation, set up, repair, maintenance and service of all medical products sold, leased or otherwise provided by the medical products wholesaler.

     (d) Maintain an inventory of medical products necessary to serve the needs of the medical products providers served by the medical products wholesaler.

     (e) Maintain a suitable physical location, other than a residence, at which the medical products wholesaler can:

          (1) Store inventory;

          (2) Repair or service any equipment which the medical products wholesaler sells, leases or otherwise provides; and

          (3) Keep all current records related to the operation of the medical products wholesaler.

     (f) Have a functioning lavatory with a toilet and a sink with hot and cold water at the facility of the medical products wholesaler.

     (g) Maintain the facility of the medical products wholesaler in a clean, orderly and sanitary condition.

     (h) Ensure that the facility of the medical products wholesaler complies with all applicable federal, state and local laws, regulations and rules, including, without limitation, occupational safety rules, fire codes, building codes and health codes.

     (i) Maintain liability insurance of at least $1,000,000, which must include product liability insurance if the medical products wholesaler:

          (1) Designs, fabricates or manufactures a medical product; or

          (2) Substantially modifies a commercially available medical product.

     (j) Maintain a log or other record regarding all repairs made to medical products provided by the medical products wholesaler. For each medical product repaired by the medical products wholesaler, the log or record must identify:

          (1) The type of medical product;

          (2) The manufacturer;

          (3) The model or model number;

          (4) The serial number;

          (5) The date of the repair;

          (6) The specific repair made;

          (7) The name of the person or company who performed the repair; and

          (8) A certification that the medical product has been returned to the specifications of the manufacturer as a result of the repair.

     2. If the medical products wholesaler cannot certify that the repaired medical product has been returned to the specifications of the manufacturer as a result of the repair, the medical products wholesaler must:

     (a) Determine whether the medical product can be safely and effectively used for a limited purpose, in which case the medical products wholesaler must note that the medical product can only be used for a limited purpose and must ensure that the medical product is only used for such limited purpose; or

     (b) Ensure that the medical product is removed from service and is not sold, leased or otherwise provided to any person without a written statement acknowledging that the medical product:

          (1) Was repaired;

          (2) Could not be brought up to the specifications of the manufacturer; and

          (3) Cannot be used for the purposes for which the medical product was intended.

     3. Any device used by a medical products wholesaler to calibrate or test equipment must be accurate and must be maintained according to the directions and specifications of the manufacturer. The scales used to weigh reservoirs of liquid oxygen must be accurate and must be certified annually by the State Sealer of Consumer Equitability.

     4. The physical premises of any medical products wholesaler must be open and accessible to the Board at all times during regular hours of operation.

     5. The owner of a medical products wholesaler is responsible for the acts of his or her facility administrator and employees.

     (Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R033-07, 8-26-2008)